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Radiation Therapy

Spine Stereotactic Radiosurgery for Spinal Cancer

Phase 2

Recruiting

Led By Samuel Chao, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI.

Karnofsky Performance Status (KPS) ≥ 70

Must not have

Patients with diffuse or multilevel metastatic spinal disease with >20% involvement of vertebral bodies, defined as involvement of >5 vertebral levels.

Patients with emergent spinal cord compression.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and for each subsequent follow-up mri (at 1 month, 3 months, 6 months and 12 months after treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two different approaches to spine SRS. One group will receive 1 treatment, and the other group will receive 2 treatments given 1 week apart.

Who is the study for?

This trial is for individuals with cancer that has spread to their spine, affecting up to three separate sites without causing spinal cord compression. Participants must be in good physical condition (KPS ≥ 70), able to undergo MRI scans, and not pregnant. Those who've had prior radiation at the index site may join, but not if they've had specific spine treatments or have certain types of cancer like lymphoma.

What is being tested?

The study compares single-session versus two-session Spine Stereotactic Radiosurgery (sSRS) for treating vertebral metastases. It aims to determine which method better prevents vertebral compression fractures after delivering high-dose x-ray treatments focused on the affected areas of the spine.

What are the potential side effects?

A potential side effect of sSRS is developing vertebral compression fractures; many are non-painful. Other risks typically associated with radiation therapy may include skin irritation near the treatment area and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread to my spine from the neck down to the lower back.

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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to more than 5 levels of my spine.

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I have a spinal cord compression that needs urgent care.

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I have a spinal bone problem causing nerve issues.

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I am able to attend all required follow-up visits and imaging.

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I have had spine surgery at the site where targeted radiation is planned.

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I have a mass near my spine larger than 5 cm.

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My spine is not stable.

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I am unable to take part in study activities due to physical or mental health issues.

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I have spinal cord compression.

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My condition affects the top of my spine or the bottom near my tailbone.

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I cannot undergo a specific type of radiation therapy.

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I have more than one type of cancer.

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My neurological condition is worsening quickly.

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I have had stereotactic radiosurgery on my spine before.

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I have a blood cancer, such as lymphoma or myeloma.

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My cancer originated in my spine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and for each subsequent follow-up mri (at 1 month, 3 months, 6 months and 12 months after treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and for each subsequent follow-up mri (at 1 month, 3 months, 6 months and 12 months after treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and for each subsequent follow-up mri (at 1 month, 3 months, 6 months and 12 months after treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS

Secondary study objectives

Local control (LC) as defined as absence of local progression of disease In the event of disease progression, all cases will be reviewed at the multi-disciplinary spine tumor board for a consensus recommendation

Pain control (PC) as assessed by the Brief Pain Inventory (BPI)

Quality of life (QOL) assessed by EORTC QLQ-C30 (with BM22)

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